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Cardiovascular and Thoracic Research

Trial to Assess Chelation Therapy in Critical Limb Ischemia – TACT3a (Protocol # 19-05-H-01)
Effects of Exercise and FITness on Left Ventricular Torsion and Wall Mechanics Study (FIT TWIST) Florida Heart (Protocol # 20-07-H-04)
Edwards PASCAL TrAnScather Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Mitral Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System Compared to Abbott MitraClip in Patients with Mitral Regurgitation (Edwards Lifesciences LLC 2018-07) (Protocol # 20-16-H-06)
Edwards PASCAL Transcatheter Valve RePair System Pivotal Clinical Trial (CLASP II TR): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Tricuspid Valve Repair with the Edwards PASCAL Transcatheter Valve Repair System and Optimal Medical Therapy (OMT) Compared to OMT Alone in Patients with Tricuspid Regurgitation (Edwards Lifesciences LLC) (Protocol # 21-02-H-03)
Secondary Tricuspid Regurgitation and Right Heart Remodeling and Mechanics Following Transcatheter Edge-to-Edge Mitral Valve Repair (STEER) (Protocol # 21-41-H-10)
Small Annuli Randomized to Evollut™ or SAPIEN™Trial (SMART Trial) (Medtronic, Inc. MDT20023EVR012) Protocol # 21-11-H-06)
COVID-19 Thrombosis Prevention Trials: Post-hospital Thromboprophylaxis (NIH) (Protocol # 21-06-H-04/WCG)

Trial to Assess Chelation Therapy in Critical Limb Ischemia – TACT3a (Protocol # 19-05-H-01)

We are currently recruiting diabetic patients with peripheral artery disease for a research study to determine if chelation therapy will improve outcomes and delay or reduce amputation. If you qualify to take part in this study, there will be no cost to you. Please call 305-674-2162 to learn if you are eligible to participate in the study.

Effects of Exercise and FITness on Left Ventricular Torsion and Wall Mechanics Study (FIT TWIST) Florida Heart (Protocol # 20-07-H-04)Effects of Exercise and FITness on Left Ventricular Torsion and Wall Mechanics Study (FIT TWIST) Florida Heart (Protocol # 20-07-H-04)

We are currently recruiting patients who have had a heart attack, for a research study to determine if cardiac rehabilitation therapy improves exercise capacity and strength of the heart muscle.

You may be a candidate for the trial if:

  • You have had a heart attack (MI) and had emergent cardiac catheterization
  • You are 18 year of age of older
  • You understand that you are being asked to participate in a research study and agree to participate.

If you qualify to take part in this study, there will not be any additional cost to you. Please call 305-674-2121 ext 56434 to learn if you might be eligible to take part in this study. Fax communications can be sent to 305-674-2169

Edwards PASCAL TrAnScather Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Mitral Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System Compared to Abbott MitraClip in Patients with Mitral Regurgitation (Edwards Lifesciences LLC 2018-07) (Protocol # 20-16-H-06)

We are currently recruiting patients diagnosed with Mitral Regurgitation (MR). You may be a candidate for the trial if:

  • You have signs and symptoms of severe or moderate-to-severe mitral regurgitation (MR), and you have been determined to be prohibited risk for mitral valve surgery.
  • You are 18 year of age of older.
  • You understand that you are being asked to participate in a research study and agree to participate.

If you qualify to take part in this study, there will not be any additional cost to you. Please call 305-674-2162 to learn if you might be eligible to take part in this study. Fax communications can be sent to 305-674-2169

Edwards PASCAL Transcatheter Valve RePair System Pivotal Clinical Trial (CLASP II TR): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Tricuspid Valve Repair with the Edwards PASCAL Transcatheter Valve Repair System and Optimal Medical Therapy (OMT) Compared to OMT Alone in Patients with Tricuspid Regurgitation (Edwards Lifesciences LLC) (Protocol # 21-02-H-03)

We are currently recruiting patients diagnosed with severe Tricuspid Regurgitation (TR). You may be a candidate for the trial if:

  • You have signs and symptoms of tricuspid regurgitation (TR), or prior heart failure hospitalization from tricuspid regurgitation, and you have been determined to be too high risk for tricuspid valve surgery.
  • You are 18 year of age of older
  • You understand that you are being asked to participate in a research study and agree to participate.

If you qualify to take part in this study, there will not be any additional cost to you. Please call 305-674-2162 to learn if you might be eligible to take part in this study. Fax communications can be sent to 305-674-2169

Secondary Tricuspid Regurgitation and Right Heart Remodeling and Mechanics Following Transcatheter Edge-to-Edge Mitral Valve Repair (STEER) (Protocol # 21-41-H-10)

We are currently recruiting patients diagnosed with Mitral Regurgitation (MR) that underwent surgical or percutaneous (Mitral Clip) Mitral Valve Repair. You may be a candidate for the trial if:

  • You had a procedure to treat mitral regurgitation (MR), and You are 18 year of age of older.
  • You understand that you are being asked to participate in a research study and agree to participate.

If you qualify to take part in this study, there will not be any additional cost to you. Please call 305-674-2121 ext 56434 to learn if you might be eligible to take part in this study. Fax communications can be sent to 305-674-2169

Small Annuli Randomized to Evollut™ or SAPIEN™Trial (SMART Trial) (Medtronic, Inc. MDT20023EVR012) Protocol # 21-11-H-06)

We are currently recruiting patients diagnosed with Severe Aortic Stenosis that are candidates for transcatheter aortic valve replacement (TAVR). You may be a candidate for the trial if:

  • You have been determined to be an eligible candidate for transcatheter aortic valve replacement (TAVR)
  • You are 18 year of age of older
  • You understand that you are being asked to participate in a research study and agree to participate.

If you qualify to take part in this study, there will not be any additional cost to you. Please call 305-674-2121 ext 56434 to learn if you might be eligible to take part in this study. Fax communications can be sent to 305-674-2169

COVID-19 Thrombosis Prevention Trials: Post-hospital Thromboprophylaxis (NIH) (Protocol # 21-06-H-04/WCG)

A multicenter, randomized trial designed to compare the effectiveness and safety of antithrombotic therapy with no antithrombotic therapy after hospitalization for 48 hours or longer for COVID-19. Participants will be enrolled prior to discharge from the hospital, to either prophylactic anticoagulant therapy (apixaban 2.5 mg bid) or placebo, and then followed for an additional 60 days after the completion of treatment (total duration of follow-up, approximately 90 days).

Recent Publications, Cardiology:

  1. Mihos CG, Horvath SA, Fernandez R, Escolar E. Left ventricular strain and myocardial work in apical hypertrophic cardiomyopathy. J Thorac Dis 2023: In Press. doi: 10.21037/jtd-23-202
  2. Right ventricular hypertrophy in apical hypertrophic cardiomyopathy.  Mihos CG, Escolar E, Fernandez R. Echocardiography. 2023 May 7. doi: 10.1111/echo.15588. Online ahead of print. PMID: 37149842
  3. Quality of Life and Type of Cardiac Resynchronization Therapy Device in Older Heart Failure Patients.  Dhande M, Myaskovsky L, Althouse A, Singh M, Weiss R, Shalaby A, Al-Khatib SM, Topoll A, Jain S, Saba S. J Palliat Med. 2023 Apr;26(4):481-488. doi: 10.1089/jpm.2022.0217. Epub 2022 Nov 8. PMID: 36350362
  4. Prediction of permanent pacemaker implantation after transcatheter aortic valve replacement: The role of machine learning.  Agasthi P, Ashraf H, Pujari SH, Girardo M, Tseng A, Mookadam F, Venepally N, Buras MR, Abraham B, Khetarpal BK, Allam M, Md SKM, Eleid MF, Greason KL, Beohar N, Sweeney J, Fortuin D, Holmes DRJ, Arsanjani R. World J Cardiol. 2023 Mar 26;15(3):95-105. doi: 10.4330/wjc.v15.i3.95. PMID: 37033682 Free PMC article.
  5. Percutaneous coronary intervention and discretionary atherectomy in patients with aortic stenosis: 2016-2019 National Inpatient Sample.  Vedantam K, Torres CA, Martinsen BJ, Donatelle M, Shehadeh M, Flaherty JD, Swaminathan RV, Rao S, Leon MB, Kirtane AJ, Beohar N. Cardiovasc Revasc Med. 2023 Mar 24:S1553-8389(23)00112-4. doi: 10.1016/j.carrev.2023.03.008. Online ahead of print. PMID: 36997465
  6. Left ventricular remodeling, mechanics, and the COAPT trial.  Mihos CG. Front Cardiovasc Med. 2023 Jan 31;10:1124727. doi: 10.3389/fcvm.2023.1124727. eCollection 2023. PMID: 36798483 Free PMC article. No abstract available.
  7. Three-dimensional functional anatomy of the human sinoatrial node for epicardial and endocardial mapping and ablation.  Kalyanasundaram A, Li N, Augostini RS, Weiss R, Hummel JD, Fedorov VV. Heart Rhythm. 2023 Jan;20(1):122-133. doi: 10.1016/j.hrthm.2022.08.039. Epub 2022 Sep 14. PMID: 36113768 Review.
  8. Device-related complications in subcutaneous versus transvenous ICD: a secondary analysis of the PRAETORIAN trial.  Knops RE, Pepplinkhuizen S, Delnoy PPHM, Boersma LVA, Kuschyk J, El-Chami MF, Bonnemeier H, Behr ER, Brouwer TF, Kaab S, Mittal S, Quast ABE, van der Stuijt W, Smeding L, de Veld JA, Tijssen JGP, Bijsterveld NR, Richter S, Brouwer MA, de Groot JR, Kooiman KM, Lambiase PD, Neuzil P, Vernooy K, Alings M, Betts TR, Bracke FALE, Burke MC, de Jong JSSG, Wright DJ, Jansen WPJ, Whinnett ZI, Nordbeck P, Knaut M, Philbert BT, van Opstal JM, Chicos AB, Allaart CP, Borger van der Burg AE, Dizon JM, Miller MA, Nemirovsky D, Surber R, Upadhyay GA, Weiss R, de Weger A, Wilde AAM, Olde Nordkamp LRA. Eur Heart J. 2022 Dec 14;43(47):4872-4883. doi: 10.1093/eurheartj/ehac496. PMID: 36030464 Free PMC article. Clinical Trial.
  9. Infection in patients with subcutaneous implantable cardioverter-defibrillator: Results of the S-ICD Post Approval Study.  Gold MR, Aasbo JD, Weiss R, Burke MC, Gleva MJ, Knight BP, Miller MA, Schuger CD, Carter N, Leigh J, Brisben AJ, El-Chami MF. Heart Rhythm. 2022 Dec;19(12):1993-2001. doi: 10.1016/j.hrthm.2022.07.031. Epub 2022 Aug 6. PMID: 35944889
  10. Positive Regadenoson Stress Test in a Patient on Phentermine With Normal Coronaries. Sendil S, Gjergjindreaj M, Lozier M, Fernandez R.Cureus. 2022 Dec 2;14(12):e32138. doi: 10.7759/cureus.32138. eCollection 2022 Dec.PMID: 36601192 Free PMC article
  11. Coronary Steal Syndrome Secondary to Large Coronary to Pulmonary Artery Fistulas.  Torres C, Gjergjindreaj M, Torres-Ortiz H, Fuentes J, Beohar N. Cureus. 2022 Oct 13;14(10):e30267. doi: 10.7759/cureus.30267. eCollection 2022 Oct. PMID: 36381934 Free PMC article.
  12. Coronary Orbital Atherectomy in Patients With Severe Aortic Stenosis. Donatelle M, Agasthi P, Parise H, Igyarto Z, Martinsen BJ, Leon MB, Beohar N. J Invasive Cardiol. 2022 Oct;34(10):E696-E700. PMID: 36200995
  13. Echocardiographic Features of Longevity: A Cross-Sectional Study of Centenarians.  Perez J, Hurwitz B, Salguero D, Donattele M, Escolar E, Fernandez R, Mihos CG. Cureus. 2022 Oct 29;14(10):e30842. doi: 10.7759/cureus.30842. eCollection 2022 Oct.PMID: 36457610 Free PMC article.
  14. The trial to assess chelation therapy 2 (TACT2): Rationale and design.  Lamas GA, Anstrom KJ, Navas-Acien A, Boineau R, Kim H, Rosenberg Y, Stylianou M, Jones TLZ, Joubert BR, Santella RM, Escolar E, Aude YW, Fonseca V, Elliott T, Lewis EF, Farkouh ME, Nathan DM, Mon AC, Gosnell L, Newman JD, Mark DB; TACT2 Investigators. Am Heart J. 2022 Oct;252:1-11. doi: 10.1016/j.ahj.2022.05.013. Epub 2022 May 19. PMID: 35598636 Clinical Trial.
  15. Dual Antiplatelet Therapy in Patients Aged 75 Years and Older with Coronary Artery Disease: A Meta-Analysis and Systematic Review.  Saint Croix G, Lacy SC, Gazzhal A, Ibrahim M, Gjergjindreaj M, Perez J, Shehadeh M, Vedantam K, Torres C, Beohar N, Escolar E. J Interv Cardiol. 2022 Sep 15;2022:3111840. doi: 10.1155/2022/3111840. eCollection 2022. PMID: 36176329 Free PMC article.
  16. Cardiac geometry, function and mechanics in left ventricular non-compaction cardiomyopathy with preserved ejection fraction.  Guigui SA, Horvath SA, Arenas IA, Mihos CG. J Echocardiogr. 2022 Sep;20(3):144-150. doi: 10.1007/s12574-021-00560-7. Epub 2022 Jan 8. PMID: 34997537
  17. Process mapping strategies to prevent subcutaneous implantable cardioverter-defibrillator infections.  Weiss R, Mark GE, El-Chami MF, Biffi M, Probst V, Lambiase PD, Miller MA, McClernon T, Hansen LK, Knight BP, Baddour LM; other members of the S-ICD Process Mapping Consortium. J Cardiovasc Electrophysiol. 2022 Jul;33(7):1628-1635. doi: 10.1111/jce.15566. Epub 2022 Jun 9. PMID: 35662315 Free PMC article. Review.
  18. Decongestion Models and Metrics in Acute Heart Failure: ESCAPE Data in the Age of the Implantable Cardiac Pressure Monitor.  Paniagua D, Levine GN, Cornwell LD, Jimenez E, Kar B, Jneid H, Denktas AE, Ma TS. Tex Heart Inst J. 2022 Jul 1;49(4):e217587. doi: 10.14503/THIJ-21-7587. PMID: 36001949 Free PMC article.
  19. Meta-Analysis of Randomized Trials Comparing Distal Transradial Versus Conventional Transradial Approach for Coronary Procedures.  Elbadawi A, Elgendy IY, Jia X, Hamed M, Shnoda M, Eid M, Rahman F, Khalid U, Paniagua D, Jneid H. Am J Cardiol. 2022 Jun 15;173:147-149. doi: 10.1016/j.amjcard.2022.02.009. Epub 2022 Apr 15. PMID: 35431049 No abstract available.
  20. Systolic anterior motion of the mitral valve in hypertrophic cardiomyopathy: a narrative review.  Guigui SA, Torres C, Escolar E, Mihos CG. J Thorac Dis. 2022 Jun;14(6):2309-2325. doi: 10.21037/jtd-22-182. PMID: 35813751 Free PMC article. Review.
  21. Impact of baseline renal dysfunction on cardiac outcomes and end-stage renal disease in heart failure patients with mitral regurgitation: the COAPT trial. Beohar N, Ailawadi G, Kotinkaduwa LN, Redfors B, Simonato M, Zhang Z, Morgan LG, Escolar E, Kar S, Lim DS, Mishell JM, Whisenant BK, Abraham WT, Lindenfeld J, Mack MJ, Stone GW. Eur Heart J. 2022 May 1;43(17):1639-1648. doi: 10.1093/eurheartj/ehac026. PMID: 35134897 Clinical Trial.
  22. Coronary orbital atherectomy treatment of Hispanic and Latino patients: A real-world comparative analysis. Beohar N, Stone GW, Martinsen BJ, Parise H, Vinardell JM, Heimowitz T, Koelbl C, Leon MB, Kirtane AJ. Catheter Cardiovasc Interv. 2022 May;99(6):1752-1757. doi: 10.1002/ccd.30158. Epub 2022 Mar 21. PMID: 35312163 Free PMC article.
  23. Feasibility of a Randomized Clinical Trial of Cardiac Resynchronization Therapy With or Without an Implantable Defibrillator in Older Patients.  Althouse AD, Jain SK, Shalaby A, Singh M, Weiss R, Myaskovsky L, Al-Khatib SM, Saba S. Circ Arrhythm Electrophysiol. 2022 Apr;15(4):e010795. doi: 10.1161/CIRCEP.121.010795. Epub 2022 Mar 31. PMID: 35357219 Free PMC article. Clinical Trial. No abstract available.
  24. Device-related infection associated with increased mortality risk in de novo transvenous implantable cardioverter-defibrillator medicare patients.  El-Chami MF, Liu Y, Griffiths RI, Knight BP, Weiss R, Mark GE, Biffi M, Probst V, Lambiase PD, Miller MA, Jacobsen CM, Baddour LM. J Cardiovasc Electrophysiol. 2022 Apr;33(4):725-730. doi: 10.1111/jce.15385. Epub 2022 Jan 31. PMID: 35066954
  25. Transcatheter Mitral Valve Implantation In Patients With Chronic Kidney Disease.  Elbadawi A, Abdelghany M, Dang A, Omer MA, Javaid AI, Eid M, Kayani WT, Paniagua D, Jneid H. Am J Cardiol. 2022 Apr 15;169:100-106. doi: 10.1016/j.amjcard.2021.12.053. Epub 2022 Jan 19. PMID: 35063264
  26. Chelation Therapy in Patients With Cardiovascular Disease: A Systematic Review. Ravalli F, Vela Parada X, Ujueta F, Pinotti R, Anstrom KJ, Lamas GA, Navas-Acien A. J Am Heart Assoc. 2022 Mar 15;11(6):e024648. doi: 10.1161/JAHA.121.024648. Epub 2022 Mar 1. PMID: 35229619; PMCID: PMC9075296.
  27. Efficacy and Safety of Appropriate Shocks and Antitachycardia Pacing in Transvenous and Subcutaneous Implantable Defibrillators: Analysis of All Appropriate Therapy in the PRAETORIAN Trial.  Knops RE, van der Stuijt W, Delnoy PPHM, Boersma LVA, Kuschyk J, El-Chami MF, Bonnemeier H, Behr ER, Brouwer TF, Kääb S, Mittal S, Quast ABE, Smeding L, Tijssen JGP, Bijsterveld NR, Richter S, Brouwer MA, de Groot JR, Kooiman KM, Lambiase PD, Neuzil P, Vernooy K, Alings M, Betts TR, Bracke FALE, Burke MC, de Jong JSSG, Wright DJ, Jansen WPJ, Whinnet ZI, Nordbeck P, Knaut M, Philbert BT, van Opstal JM, Chicos AB, Allaart CP, Borger van der Burg AE, Clancy JF, Dizon JM, Miller MA, Nemirovsky D, Surber R, Upadhyay GA, Weiss R, de Weger A, Wilde AAM, Olde Nordkamp LRA; PRAETORIAN Investigators‡. Circulation. 2022 Feb;145(5):321-329. doi: 10.1161/CIRCULATIONAHA.121.057816. Epub 2021 Nov 14. PMID: 34779221 Clinical Trial.
  28. Edetate disodium infusions may benefit patients with diabetes and critical limb threatening ischemia. Vascular Disease Management. Ujueta F, Arenas IA, Vozzi C, Lamas GA. 2022;19:E96-E101
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